Director of Regulatory Affairs

The Director of Regulatory Affairs is responsible for the regulatory strategy and systems, and for ensuring that the company's products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable. The Director of Regulatory Affairs is also responsible for working with sister manufacturers, to assist with communications with relevant authorities and to provide clarification and advice on regulatory requirements. The Director of Regulatory Affairs is a member of the senior management team and the global Regulatory Affairs leadership.

Position: Director, Regulatory Affairs

Reporting to:Vice President and General Manager

Responsibilities:

Direct, mentor and manage the Regulatory Affairs department ensuring resources and expertise are assigned to meet company goals and objectives.

Ensure the regulatory systems and procedures meet the necessary regulatory requirements pertaining to company registration and product marketing authorisation where the products are for sale.

Ensure that the products are appropriately registered and maintained in all countries where they are for sale - manage and maintain country restrictions as necessary.

Ensure that as directed by sister companies their products are appropriately registered and maintained for sale within the EMEA - manage and maintain their country restrictions as necessary

Ensure that complaints are assessed for regulatory reporting including the associated correspondence to applicable regulatory authorities.

Provides regulatory support to the functional units such as CSD, DCM, Engineering, Quality Assurance and Operations.

Liaise with regulatory authorities as necessary and appropriate for both pre-market authorisation and post market surveillance activities.

Official Correspondent/Contact Person for regulatory authorities as required.

Meet and engage with regulatory authorities (Competent Authorities, Notified Bodies and global regulatory agencies as required) to understand their needs and expectations.

Develop and advise on regulatory strategies for new, existing and changing products in collaboration with Engineering, Quality Assurance, Divisions, clinical and other stakeholders as appropriate.

Work with regulatory groups locally and globally to develop and implement strategies for the most efficient and timely submission and approval of regulatory filings.

Identify and monitor legislative and regulatory activities and report their potential impact on the company to local and global leadership as necessary.

Ensure compliance to global policies, procedures and direction.

Manage regulatory costs and ensure a full understanding of departmental expenditure and budget.

Contribute and work as part of the senior management team to help create a synergistic and cohesive environment.

Undertake people management responsibilities to the direct reports to this role, including but not restricted to, generating training and development plans, carrying out performance appraisals and dealing with performance related issues.

Provide coaching and support to direct reports in their day to day roles and act as a point of escalation where necessary for specific issues that may arise.

Ensure open communication channels are maintained across all teams within the Regulatory function, and that all relevant information is cascaded appropriately and in a timely fashion.

Seek out continuous improvement best practice with an emphasis on what can be learned and implemented to drive efficient processes.

Follow local policies and procedures including but not limited to health and safety, human resources, travel and expense reporting

Designees for this position are the Regulatory Affairs Managers.

Ensure that the company’s Code of Conduct is considered within all business matters carried out on the company’s behalf.

Qualifications / Requirements:

Bachelor's degree in life sciences or chemistry. An advanced life science degree (e.g. MS, PhD) is preferred.